Kornimate/medical-research-clean huggingface dataset:
randomized crossover trial for the evaluation of the possible effects in the intestine of two different pharmaceutical forms of l - thyroxine in patients with primary acquired hypothyroidism

Conditions: Hypothyroidism

Summary: thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal impairment, such as celiac disease. a study reported an increased prevalence of celiac disease in a large cohort of children affected by congenital hypothyroidism, underlying the relationship between these two conditions. the hypothesis of our study is that the onset of celiac disorder may be related to the gut concentration of thyroid hormone (th) in hypothyroidism patients treated with replacement therapy. in fact, th replacement therapy showed a low bioavailability with a consequent high gut concentration. two different pharmaceutical formulations (liquid and solid, per os) are available. the liquid one has a better absorption profile and bioavailability than the solid; therefore, it is associated with a low th intestinal concentration. according to our hypothesis, the solid th formulation could increase the microbial diversity in the gut instead of the liquid form, due to the high local th concentration. based on these findings, the purpose of this study is to evaluate the effect of two different pharmaceutical formulations of th on the gut in terms of modification of gut microbiota, inflammatory parameters and gut absorption.


Eligibility criteria:
inclusion criteria: * children with primary acquired hypothyroidism that require levothyroxine therapy (naïve patients, \< 18 years) * informed consent from parents and patient exclusion criteria: * age \< 3 years * patients with secondary hypothyroidism, euthyroid sick syndrome or thyroid hormone resistant * patients with celiac disease, type i diabetes or other known autoimmune diseases * patients with genetic diseases or syndromes, such as down, williams-beuren, turner * assumption of antibiotics, probiotics, prebiotics, or other medications that could affect the gut microbiota in the month before the beginning of the study * gastrointestinal infectious diseases in the month before the beginning of the study * hypersensitivity to levothyroxine or any of the ingredients contained in the two pharmaceutical formulations * untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis. * patients with cardiovascular disease * patients who show with impaired pancreatic function measured using the assay in faecal fat (steatocrit) at the screening visit

Keywords: hypothyroidism microbiota thyroid hormone l-thyroxine celiac disease
effects of backward gait on sand on improving the gait parameters of patients with chronic stroke.

Conditions: Chronic Stroke

Summary: gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. the aim is not simply walking in controlled environment, but to achieve dynamic walking. dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.


Eligibility criteria:
inclusion criteria: * had experienced stroke for the first time. * unilateral involvement. * demonstrate motor stage 3 or 4 on brunnstrom motor recovery. * able to walk 12 m with or without assistive devices. * medically stable. * able to follow simple commands. exclusion criteria: * patient exhibits comorbid disease other than stroke that may affect gait. * any conditions contra indicated to exercises * any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.

Keywords: backward walking, stroke, gait training
study to assess safety of azd7762 administered alone and in combination with gemcitabine in patients with advanced solid malignancies

Conditions: Solid Tumors

Summary: this is an open-label, multi-center, dose-escalation, phase i study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of azd7762 administered as a single intravenous unit and in combination with gemcitabine. the study is sponsored by astrazeneca.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * ecog performance status of 0 or 1 * patient and tumor type must be suitable for treatment with weekly standard gemcitabine. exclusion criteria: * inadequate bone marrow reserve, inadequate liver function or impaired renal function * any troponin elevation (above normal range) * stage ii, iii, or iv cardiac status, according to new york heart association (nyha) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction \[mi\]) * any prior anthracycline treatment

Keywords: mixed solid tumors
lateral ridge augmentation using two graft combination and a cross-linked collagen membrane

Conditions: Alveolar Bone Resorption

Summary: to treat resorbed alveolar ridges, many surgical procedures are available in the literature such as ridge splitting, distraction osteogenesis, block grafting techniques and guided bone regeneration, which is the most documented technique. various grafting materials are available but there is a lack of evidence on the superiority of a material or a combination of materials.

bone width at the implant site is an important prerequisite for a predictable and long-term prognosis in implant dentistry. different types of membranes and bone grafts are used in the gbr procedure. however, there is a lack of studies in the literature about the combination allograft/xenograft. the aim of the present trial is to compare two different bone graft combinations (autogenous-xenogeneic and allogeneic-xenogeneic) covered with a cross-linked collagen membrane in a horizontal alveolar ridge augmentation (without simultaneous implant placement).

Eligibility criteria:
inclusion criteria: * healthy patients, non-smokers or smokers \<10 cigarettes/day. * age between 20 and 75. * full mouth bleeding score (fmbs) \<20 %. * full mouth plaque score (fmps) \<15%. * residual bone width \< 5 mm and adequate bone height in the maxilla and the mandible. * tooth extraction performed at least 6 weeks before surgery. * presence of enough teeth to support an occlusal stent/radiographic guide. exclusion criteria: * systemic diseases. * heavy smokers (\> 10 cigarettes/day). * history of radiotherapy in the head and neck region in the last 5 years. * active periodontitis on the remaining teeth. * pregnancy. * intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin d and metabolites at therapeutic levels within the last 6 months).
treatment of post operative pain in thyroid surgery patients: perspective study acupuncture versus drugs

Conditions: Post Operative Pain

Summary: the aim of the study was to evaluate if acupuncture may reduce intraoperative ultiva (remifentanil) consumption and post operative pain measured with vas, italian version mc gill questionnaire pain and drug consumption (acetaminophen daily consumption).

the aim of the study was to evaluate if acupuncture may reduce intraoperative ultiva (remifentanil) consumption and post operative pain measured with vas, italian version mc gill questionnaire pain and drug consumption (acetaminophen daily consumption). the study involve patients who underwent thyroid surgery randomised in two groups. a group patients treated with drugs and b group patients treated with drugs and acupuncture.acupuncture related risk are pain, faint and haematoma.the study will be done in padova university hospital (endocrine unit.primary end point will be vas pain and secondary end points ultiva consumption, post operative pain measured with italian version of mc gill questionnaire pain and acetaminophen daily intake

Eligibility criteria:
inclusion criteria: * thyroid surgery patients exclusion criteria: * back severe arthritis * osteoporosis * myofascial pain * rheumatic disease * fibromyalgia * systemic cardiovascular and respiratory disease * hypertension * drug or alcohol consumption * mental disease * cervical trauma * chronic use of antidepressant * hypnotic and antihypertensive drugs

Keywords: post operative pain acupuncture
study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects

Conditions: Acute Low Back Pain

Summary: a randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.


Eligibility criteria:
inclusion criteria: * bmi : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(icf) exclusion criteria: * evidence of clinically relevant pathology within 30 days prior to drug administration history of relevant drug and/or food allergies
diabetes adolescent and family group therapy

Conditions: Type 1 Diabetes Mellitus

Summary: in this research study the investigators want more about how being in a group about diabetes helps your family versus individual treatment. the investigators are now asking youth with recently diagnosed (\<1 year) diabetes and their parents to be in the research, because the investigators want to see if this diabetes group and/or individual therapy is helpful to your coping, adjustment, and family communication about diabetes.

the purpose of this research study is to find out what effects the group therapy project has on parents and child's management of type 1 diabetes mellitus (t1dm) from both a group versus an individual therapy modality. we want to start a group and individual therapy program that looks at youth and family adjustment and coping at the cincinnati children's hospital with patients who have t1dm. there has been research before on this group therapy and we want to look at it in a "typical" clinical setting at cincinnati children's hospital for both group and individual therapy, including recently diagnosed patients (\<1 year). this research is being done to understand how a peer and family-based group versus individual therapy can be helpful by looking at survey data as well as medical data before and after participating in the diabetes therapy program. this information will help us further develop prevention and intervention programs for other youth with t1dm and their families.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes, * aged 10.0 - 17.9 years of age, * at least one parent/caregiver to participate with them, * diagnosed for at least 6 months for the group and the individual arms. * diagnosed for \<1 year for the recently diagnosed arm exclusion criteria: * potential participants will be excluded if: * they have a co-existing diagnosis of mental retardation, pervasive developmental disorder, substance abuse, eating disorders, psychosis, or other acute psychiatric or medical needs, such as suicidality * they are not fluent in the english language.

Keywords: youth family group therapy type 1 diabetes mellitus self-management
detecting the rest tremor associated with parkinson's disease using analysis of the muscle contractions rhythmicity

Conditions: Parkinson; Cerebellar Tumor; Rest Tremor; Diagnoses Disease; Movement; Abnormal, Involuntary

Summary: resting tremors associated with parkinson's disease (pd) remains difficult to quantify and track during disease progression. this study propose to explore the rhythmicity of distal muscle contractions in the upper limb to characterize resting tremor and discriminate it from cerebellar tremor (ct) based on the frequency spectrum of the emg signal.

this retrospective study analyzed surface emg recordings of wrist flexor-pronators and extensor-supinators from patients with pd or ct bilaterally in five 10-second conditions: rest with contralateral motor distraction, symmetrical arms extended forward posture with hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. the rhythmicity index (ri) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12hz.

Eligibility criteria:
inclusion criteria: * patient who performed surface emg recordings of wrist flexor-pronators and extensor-supinators in laboratories; * diagnosis of parkinson's disease or cerebellar tremor. exclusion criteria: * botulinium toxin injection in upper limb during a delay of 3 months before surface emg recordings; * levodopa drugs administrated during a delay of 12 hours before surface emg recordings; * tremor-favour drugs administrated during a delay of 30 days before surface emg recordings; * presence of an other neurologic disease or of any disease associated with motor disorders in upper limb.
efficacy of additional titration during oral appliance treatment for sleep-disordered breathing.

Conditions: Obstructive Sleep Apnea Syndrome

Summary: in the protocol "predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (promad)", 100 patients with obstructive sleep apnea are included and started mad treatment at 75% of maximal protrusion. all patients underwent polysomnography with mad in situ to evaluate the effect of the mad on severity of sleep apnea. if the results of the polysomnography with mad are unsuccessful (defined as a reduction in ahi with the mad in situ of less than 50% compared to baseline), the therapy needs to be adjusted. finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of mad therapy. in patients with insufficient results on the polysomnography with the mad at 75% of maximal protrusion, the mad will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the mad. after habituation and adaptation period but within 2 months after the first polysomnography with mad, a new polysomnography will be performed to assess the effect of the 90% protruded position.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * body mass index (bmi) ≤ 35 kg/m² * osas, as defined by the american academy of sleep medicine task force * apnea-hypopnea index (ahi) \< 50 * incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion exclusion criteria: * other sleep disorders (i.e. parasomnias) * invasive upper airway surgery for sleep-disordered breathing * known genetic disorders with craniofacial and/or upper airway malformations * use of benzodiazepine and/or antidepressants * known history of psychiatric disease * known history of fibromyalgia and/or chronic fatigue syndrome * dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for mad use
sequential dose-escalation study to assess the safety, tolerability and pharmacokinetics of tb006 in healthy subjects

Conditions: Alzheimer Disease

Summary: this is a single dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of tb006, a monoclonal antibody that will be studied as a disease modifying treatment for alzheimer's disease.

the tb006 nonclinical pharmacology program establishes its potential as a therapeutic agent for ad. overall, the data suggest the potential for beneficial therapeutic effects of tb006 in addressing underlying pathology and ameliorating the course of ad. the preclinical safety profile of tb006 further supports the clinical investigation of tb006. this is a phase 1 sad study in healthy adult subjects. the study will evaluate the safety, tolerability, and pk of single doses of tb006, administered as an iv infusion over 1 hour.

Eligibility criteria:
inclusion criteria: * healthy volunteers, male or female 18-55 at the time of informed consent * in good health as determined by the principal investigator * body weight of ≥ 50 kg and bmi within the range 18-30 kg/m2 (inclusive). * chinese subjects are eligible to be included in the study if all of the following criteria apply in addition to the above: must have been born in china, with 2 chinese biological parents and 4 chinese grandparents as confirmed by interview; must have lived no more than 10 years outside of china; must not have changed their lifestyle or habits significantly, including diet, since leaving china. exclusion criteria: * any current history of clinically significant disease in the opinion of the investigator or receiving maintenance medications on a daily basis. * any active or unstable clinically significant medical or psychiatric condition as judged by the investigator. * smokes cigarettes or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers), and has done so in the 3 months prior to screening. * regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \> 20 units for males or \> 16 units for females. one unit is equivalent to 8 glasses of alcohol: a half pint (∼240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

Keywords: alzheimer disease
high- and low-dose radiotherapy combined with pd-1 inhibitors for mss crlm

Conditions: Colorectal Liver Metastases

Summary: this pilot phase i trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (pd-1) inhibitors in microsatellite stable (mss) metastatic colorectal cancer (mcrc) that have failed second-line immunotherapy or above.

this pilot phase i trial aims to investigate the efficacy and safety of high- and low-dose radiotherapy combined with programmed cell death-1 (pd-1) inhibitors in microsatellite stable (mss) metastatic colorectal cancer (mcrc) that have failed second-line immunotherapy or above. 30 participants will be enrolled in this study. all will take part at jiangsu cancer hospital.

Eligibility criteria:
inclusion criteria: 1. patients with microsatellite stable colorectal liver metastases and failure with second-line or above therapy, and no subsequent standard treatment regimen. 2. patients with an ecog score of 0 or 1, and an expected survival period of ≥6 months. 3. during the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, chinese herbal medicine, and proprietary chinese medicine. 4. 18-70 years old, no gender limit. exclusion criteria: 1. those with a history of severe immediate allergy to the drugs used in this study. 2. cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc. 3. any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia onset or symptomatic pulmonary embolism. patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. if appropriate, you can consult a cardiologist. 4. patients with active infection requiring systemic treatment.

Keywords: microsatellite stable pd-1 inhibitors abscopal effects
negative pressure therapy after infected mesh removal.

Conditions: Infection, Surgical Site

Summary: chronic mesh infection mesh is a complication with leads to a long hospital stays, reoperation and admissions through emergency department. surgical site infection (ssi) after removal are 58-72.7% depending on the published series. new therapeutic lines are needed in order to improve outcomes after surgery such as negative pressure therapy. the main objective is to determine the ssi differences depending on the use of negative pressure therapy after infected mesh removal. material and methods: multicentric, prospective, randomized and an open comparative study. patients will be selected sequentially n=94. each selected patient will be randomized in two groups: conventional closure of the surgical wound vs. negative pressure therapy with a 30-day follow-up.

the surgeon will not know the patient's arm of study before the operation. once the wound will be closed, we will let know what kind of closure the patient will need. negative pressure therapy will be the same in all patients, in order to mantain homogeneity. we will set appointments each day while he is hospitalized, and after the discharge: at 7 (+/- 1) and 30 (+/- 5). we will collect demographic data before and during surgery, as well as in the postoperative period, including appointments.

Eligibility criteria:
inclusion criteria: * any gender, adult. age minimum limits 18. * infected chronic mesh. * signing of informed consent. exclusion criteria: * enterocutaneous fistula or enteroatmospheric fistula. * infected chronic mesh related to parastomal hernia. * patients who will no complete the follow-up period. * informed consent denial.
effect of specially designed balance board on standing balance in children with diplegic cererbral palsy

Conditions: Balance Board; Standing Balance; Diplegic Cerebral Palsy

Summary: this was done to: 1. to determine the effect of a specially designed balance board on balance ability. 2. to determine the effect of the traditional balance training program on balance ability. 3. to compare between the effect of a specially designed balance board and the traditional balance training program on balance ability.

children with cerebral palsy (cp) often experience abnormal posture, loss of motor control, and poor trunk control, leading to limitations in daily activities. improving balance abilities is crucial for maintaining equilibrium in sensory environments. vestibular stimulation can help develop feed-forward mechanisms and new functional skills. this study aims to improve balance abilities in children with diplegic cp, explore the impact of balance boards on vestibular and hand function, and assist mothers in their child's improvement.

Eligibility criteria:
inclusion criteria: 1. their ages ranged from 4 to 8 years old. 2. the degree of spasticity ranged from grade 1 or 1+ according to modified ashworth scale 3. they were at level i or ii on gross motor function classification scale. 4. they were able to follow verbal command or instructions. exclusion criteria: children were excluded if they had one of the following : 1. fixed deformities of lower limbs. 2. visual or auditory problems. 3. history of surgical interference in lower limbs less than six months. 4. botulinum toxin injections to the lower limb during the previous 4 months. 5. mental retardation. 6. fixed deformity